Vaginal microbicides are compounds that may protect women from HIV and other sexually transmitted infections (STIs). This study will determine the safety of the microbicide UC-781 by comparing the effects of keeping the microbicide in the vagina for different lengths of time.

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Local and systemic safety of a one-time dose of UC-781 0.1 % gel for vaginal use at different durations of exposure in HIV uninfected women [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Persistence of UC-781 0.1% gel following a single application [ Time Frame: At 0, 2, 4, or 8 hours post application ] [ Designated as safety issue: No ]

Systemic absorption of UC-781 following a single application of 0.1% UC-781 gel [ Time Frame: At 0, 2, 4, or 8 hours post application ] [ Designated as safety issue: No ]

Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 8 hours

Drug: UC-781

0.1% UC-781 Vaginal Gel

Placebo Comparator: 1B

Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 8 hours

Drug: UC-781 placebo

Vaginal Gel Placebo

Experimental: 2A

Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 4 hours

Drug: UC-781

0.1% UC-781 Vaginal Gel

Placebo Comparator: 2B

Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 4 hours

Drug: UC-781 placebo

Vaginal Gel Placebo

Experimental: 3A

Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 2 hours

Drug: UC-781

0.1% UC-781 Vaginal Gel

Placebo Comparator: 3B

Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 2 hours

Drug: UC-781 placebo

Vaginal Gel Placebo

Experimental: 4A

Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 0 hours

Drug: UC-781

0.1% UC-781 Vaginal Gel

Placebo Comparator: 4B

Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 0 hours

Drug: UC-781 placebo

Vaginal Gel Placebo

Detailed Description:

Vaginal microbicides are compounds applied to the inside of the vagina that may protect women against vaginal transmission of HIV and other STIs. This study will evaluate the safety of the vaginal microbicide UC-781. Studies have shown UC-781 to be an effective inhibitor of HIV-1 reverse transcriptase. UC-781 has been tested in animal models and in Phase I and II studies in humans. The results of these studies indicated that cervical tissue was fully protected from different variants of HIV. The purpose of this study is to assess the incidence of epithelial disruption and inflammation in the cervix, vagina, and vulva of healthy HIV uninfected women after a single exposure to UC-781 vaginal gel. This study will compare the results of leaving the microbicide in the vagina for varying lengths of time.

The duration of this study is approximately 35 days. Participants in this study will be randomly assigned to one of eight groups, and all participants will receive a single exposure of UC-781 or placebo gel. There will be five total study visits, including the screening and study entry visits. Screening will occur approximately 10 days prior to the study entry visit. At study entry, a single application of microbicide or placebo gel will be inserted for 0, 2, 4,or 8 hours in the vagina. Length of exposure time will differ, depending on which group a participant has been randomly assigned to. Following vaginal exposure to the microbicide, the microbicide will be rinsed off. Vaginal secretions will be collected to test antiviral activity against HIV and assess the amount of microbicide remaining in the vagina. Visits 3 through 5 occur at approximately 24 to 48 hours, 6 to 8 days, and 25 to 35 days following study entry.

At all visits, participants will be asked to complete a questionnaire and undergo a pelvic exam, STI tests, and vital signs measurements. Blood and urine collection will occur at each visit. On selected visits, a colposcopy will be conducted and participants will be interviewed regarding product acceptability, in addition to other measures. Between selected visits, participants will be asked to maintain sexual abstinence or use condoms.

Any condition that, in the opinion of the investigator, would interfere with the study

Intravaginal use of any device or product (except tampons) 7 days prior to study screening

Surgical procedure involving the pelvis in the 90 days prior to enrollment (e.g., dilation and curettage or evacuation, cervical biopsy, cryosurgery,any other surgery involving pelvic organs or area)

Abnormal pelvic exam finding that, in the opinion of the investigator would complicate interpretation of the colposcopy

Pregnancy, or within 90 days of last pregnancy

Breastfeeding

Exclusion Criteria for Study Entry:

Meets any of the exclusion criteria of the screening visit

Diagnosed or suspected reproductive tract infection or urinary tract infection. More information on this criterion can be found in the protocol.

Menses or other vaginal bleeding anticipated in the 8 days following study entry

Injected nontherapeutic drugs between study screening and study entry

Certain abnormal laboratory values

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441909